SafeOp 3

GUDID 00190376560021

SafeOp 3 Delta Dilator Kit, Sterile - Circle

ALPHATEC SPINE, INC.

Neurophysiologic monitoring system

• Primary Device ID: 00190376560021
• NIH Device Record Key: 3145a743-468c-46e6-b200-923766640fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeOp 3
• Version Model Number: AIX1360-S
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376560021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234092

FDA Product Code

• PDQ: Neurosurgical nerve locator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-23
• Device Publish Date: 2024-07-15

On-Brand Devices [SafeOp 3]

• 00190376549392: SafeOp 3 Stimulating Ball-Tip Probe, Sterile
• 00190376549378: SafeOp 3 Stimulating Clip, Sterile
• 00190376560021: SafeOp 3 Delta Dilator Kit, Sterile - Circle
• 00190376549408: SafeOp 3 MEP Activator, Sterile
• 00190376549385: SafeOp 3 Delta Stimulating Clip, Sterile
• 00190376542942: SO3 Dual Surface Electrode 6-pack
• 00190376537238: SafeOp 3 Thoracolumbar Electrode Kit - EMG/SSEP/MEP – Surface
• 00190376537221: SafeOp 3 Thoracolumbar Electrode Kit - EMG/SSEP/MEP - Needle
• 00190376537214: SafeOp 3 PTP/LTP Electrode Kit - EMG/SSEP/MEP - Surface
• 00190376537207: SafeOp 3 PTP/LTP Electrode Kit - EMG/SSEP/MEP - Needle
• 00190376537191: SafeOp 3 Cervical Electrode Kit - EMG/SSEP/MEP - Surface
• 00190376537184: SafeOp 3 Cervical Electrode Kit - EMG/SSEP/MEP - Needle
• 00190376537177: SafeOp 3 Thoracolumbar Electrode Kit - EMG/SSEP - Surface
• 00190376537160: SafeOp 3 Thoracolumbar Electrode Kit - EMG/SSEP - Needle
• 00190376537153: SafeOp 3 PTP/LTP Electrode Kit - EMG/SSEP - Surface
• 00190376537146: SafeOp 3 PTP/LTP Electrode Kit - EMG/SSEP - Needle
• 00190376537139: SafeOp 3 Cervical Electrode Kit - EMG/SSEP - Surface
• 00190376537122: SafeOp 3 Cervical Electrode Kit – EMG/SSEP - Needle
• 00190376537115: SafeOp 3 Electrode Kit – EMG Only - Surface
• 00190376537108: SafeOp 3 Electrode Kit – EMG Only - Needle
• 00190376530024: Patient Interface Power Supply
• 00190376517506: SafeOp 3 Patient Interface